TRIGEN 71645032Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556215647), received between Dec 10, 2020 and Nov 5, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K111025, K161264, K210980); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT, AFTER AN INTERNAL FIXATION PROCEDURE HAD BEEN PERFORMED ON THE PATIENT'S LEFT FEMUR ON (B)(6) 2016 TO TREAT A FEMORAL SHAFT AND INTERTROCHANTERIC FRACTURE, THE PATIENT EXPERIENCED PAINFUL NONUNION OF THE FEMORAL SHAFT FRACTURE AND BREAKAGE OF THE TWO (2) DISTAL INTERLOCKING SCREWS 46.7 WEEKS POSTOPERATIVELY (AS CONFIRMED PER X-RAY ASSESSMENT). A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 TO TREAT THIS ADVERSE EVENT. ADDITIONAL DETAILS REGARDING THE CLINICAL COURSE OF THE PATIENT WERE NOT PROVIDED. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF)], ADDITIONAL INFORMATION IS NOT KNOWN, AND IT IS NOT POSSIBLE TO COLLECT IT, WE DO NOT HAVE THE OPPORTUNITY TO REVISIT NEGATIVE FEEDBACK TO RETRIEVE FURTHER INFORMATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Device Embedded In Tissue or Plaque; Failure of Implant; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15741081 ↗
• InjurySep 27, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED PAIN ON (B)(6) 2021. THIS ADVERSE EVENT WAS TREATED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2021. THE SURGEON DETERMINED THIS FAILURE WAS DUE TO A NON-UNION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12537496 ↗
• InjuryDec 10, 2020Connection Problem; Material Deformation; Connection Problem; Material Deformation

  IT WAS REPORTED THAT DURING INTERTAN NAIL SURGERY, THE MOST DISTAL SCREW INTERFERED WITH THE OUTSIDE THE SCREW HOLE ON THE NAIL. THEN THE CONNECTING PART ON THE SCREW HEAD WAS STRIPPED WHILE THE SURGEON ATTEMPTING TO REMOVE THE SCREW. FINALLY, THE SURGERY COMPLETED WITHOUT REMOVING THE SCREW. THE SCREW LEFT INSIDE THE PATIENT. 60 MINUTES SURGICAL DELAY. NO SERIOUS INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10985256 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111025, K161264, K210980. One submission often covers many models, so check the product and lot details in each record.

• Z-2456-2026 · Mar 16, 2026 · Open, Classified
  TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
• Z-2443-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
• Z-2444-2023 · Jul 24, 2023 · Open, Classified
  TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT, REF 71647340, Femur nail
• Z-1132-2013 · Mar 6, 2013 · Terminated
  TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery